北京生物医学工程

ChinaHeart左心辅助装置的体内动物实验评估

In vivo survival evaluation of the ChinaHeart ventricular assist device

作者：蔺嫦燕吴广辉刘修健徐创业侯晓彤李海洋陈琛杨朋渠文波

单位：首都医科大学附属北京安贞医院（北京100029）

关键词： ChinaHeart VAD；左心室辅助；磁悬浮血泵；在体实验；评估

分类号：

出版年·卷·期（页码）：2013·32·5（472-478）

摘要：

目的通过体内动物实验验证磁悬浮左心辅助装置——ChinaHeart VAD的运行可靠性及血液相容性，并

观察ChinaHeart VAD对实验动物主要终末器官的影响。方法择健康雄性绵羊6只，麻醉诱导、呼吸插管后开

胸，将ChinaHeart VAD植入体内。在心脏不停跳的情况下，形成由左心尖到辅助装置，再到降主动脉的辅助

循环通路。术后常规护理并抗凝控制，术前和术后不同时间段分别做游离血红蛋白、血细胞和血液生化指标

检查。术后连续监测辅助装置运行状况，待动物存活至预期时限进行安乐死手术，尸解做VAD内血栓探查及

动物终末主要脏器的宏观和病理检查。结果6例实验中，1台VAD在植入25d后停止运转，其余5台正常运转至

实验结束；6例实验动物中有1例在术后第3天因肺部感染死亡，其余5例VAD植入后存活状态良好，术后细胞

学和血液生化学检查结果均值在正常范围内；血浆中游离血红蛋白数值小于 9.78mg/dL；因VAD停转行安乐

死动物尸解时发现，血泵入口形成一个疑似来源于心肌内膜的增生组织，且叶片与泵壳之间同时附着一块血

栓，其余5例装置内无任何附着物或血栓；组织病理学检查发现2例动物左肺贴近VAD装置部位均可见有小叶

性肺炎，2例动物肾脏有局部坏死，其余终末脏器无明显病变发生。结论ChinaHeart VAD具有较好的可靠性

，完全可以胜任长于一个月的连续心室辅助，且具有极优的血液相容性，对各主要终末脏器无显著影响。

Objective To evaluate the reliability hemocompatibility，and end-organ effects of

the ChinaHeart VAD, a magnetic left ventricular assist device, by in vivo experimental

investigation．Methods Under anesthesia，via left lateral thoracotomy and ventilator assisted

breathing，every one of 6 healthy male sheep was completed as such model, in which the inflow

cannula was inserted into the left ventricular apex on beating hearts，and the outflow graft

was anastomosed to the descending aorta．Postoperative nursing and anticoagulating were

completed routinely, the hematologic and biochemical tests were performed preoperatively and

postoperatively to evaluate peripheral organ functions．ChinaHeart VAD operating parameters

were recorded continuously until termination of the experiment．At the end of the experimental

period the sheep was humanely killed，and the end-organs were examined macroscopically and

histopathologically．Results Only one of six VADs stopped running at 25th day postoperatively

because of thrombus between impeller and housing, and all of others was working until in vivo

experiment terminated. One sheep died at 3rd day because of respiratory failure, others

survived and their hematological and biochemical data showed no evidence of organ dysfunction

during the experimental period．The maximum value of free hemoglobin in plasma was 9.78mg/dL.

In this VAD which stopped running at 25th day postoperatively, we found a piece of hyperplasia

tissue suspiciously from myocardial intima blocking at entrance, thrombus between impeller and

shell, other pump’s inner, inflow and outflow conduits were free of thrombus at terminal

autopsy. Histopathological examination revealed two sheep with lobular pneumonia at left lung

where closed to device, and two sheep with kidney local necrosis, however the other end organs

without obvious pathological changes. Conclusions The ChinaHeart VAD system demonstrated

excellent reliability and hemocompatibility during more than thirty-five days supporting

continuously，and had no significant side effect on the major end-organs.

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